Identity
- Trade Name
- Flecta Disposable Mirrors EUDAMEDFDA UDI
- Generic Name
- Dental mirror, reusable FDA UDI
- Device Name
- Flecta EUDAMEDBox of 200 FDA UDI
- Model / Reference
- FLEC EUDAMEDFDA UDI
- Description
- Box of 200 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701FLEC2 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D701FLEC9N EUDAMED
- Unit of Use DI
- D701FLEC1 EUDAMED
- FDA Product Code
- EAX FDA UDI
- EMDN Code
- Q010504 DENTISTRY MIRRORS AND STYLETS, SINGLE-USE EUDAMED
- GMDN Term
- Dental mirror, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Flecta Disposable Mirrors by Pulpdent Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D701FLEC9N | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- EUDAMED SRN
- US-MF-000004897
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED d2183d64-4c4e-49cf-85fe-2658213bcc9f 61 fields · synced Jun 19, 2026
- FDA UDI 777649db-ab73-4c59-a53f-07a1048ff37d 33 fields · synced May 30, 2026